Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer

NCT04743934 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB-3000068805R21CA259808-02
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blinded, placebo-controlled randomized phase II clinical trial investigating whether flibanserin promotes sexual interest in men with prostate cancer who are receiving androgen suppression.

Conditions

Prostate Adenocarcinoma

Keywords

Flibanserin; Androgen Deprivation Therapy (ADT)

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Reported Attempting Sexual Intercourse at Least 3 Times in the Prior Month

  The number of patients in each arm reporting attempting sexual intercourse at least 3 times in the prior month (0-2 attempts vs. 3+ attempts) will be compared using the two-group chi-square test, or Fisher's exact test if the assumptions for the chi-square test are not tenable.

  Baseline up to 12 weeks

Secondary Outcomes (2)

• Sexual Quality of Life (QoL)

  12 weeks

• Frequency of Patient Reported Grade 3+ Adverse Events

  Baseline up to 12 weeks

Study Arms (2)

Flibanserin + ADT

EXPERIMENTAL

Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).

Drug: Flibanserin 100 MG; Drug: Androgen deprivation therapy

Placebo + ADT

PLACEBO COMPARATOR

Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).

Drug: Placebo; Drug: Androgen deprivation therapy

Interventions

Flibanserin 100 MG DRUG

Flibanserin 100mg tablets taken by mouth daily at bedtime

Flibanserin + ADT

Placebo DRUG

Visually identical placebo tablets taken by mouth daily at bedine

Placebo + ADT

Androgen deprivation therapy DRUG

Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.

Flibanserin + ADT; Placebo + ADT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Ability to take oral medication and be willing to adhere to the study regimen.
• Male age \>18 years.
• Histologically confirmed prostate cancer.
• Currently receiving gonadotropin releasing hormone agonist/antagonist monotherapy.
• Serum testosterone \<50 ng/dL.
• Serum AST and ALT less than 2 times upper limit of normal.
• Endorsed reduced sexual interest.
• Attempted intercourse.
• Current sexual partner.
• Was sexually active with partner within 6 months prior to ADT.
• No other antineoplastic therapy planned during study period.
• No active symptoms attributable to systemic prostate cancer.

You may not qualify if:

• Current systemic prostate cancer treatment besides GnRH agonist/antagonist, anti-androgens, or abiraterone.
• Prior to ADT had erections not firm enough for intercourse despite use of pharmacologic agents such as phosphodiesterase-5 inhibitors.
• Current symptoms attributable to active prostate cancer
• Moderate or heavy alcohol use (\>2 drinks/day)
• Concurrent moderate or strong CYP3A4 inhibitors
• Concurrently taking medication classified as a monoamine oxidase inhibitor.

Sponsors & Collaborators

• Andrew McDonald: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Interventions

flibanserin; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Andrew McDonald, MD
• Organization: The University of Alabama at Birmingham

ammcdonald@uabmc.edu

205-410-3713

Study Officials

• Andrew McDonald, MD

  University of Alabama at Birmingham (UAB)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: July 2, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 20, 2026
• Results First Posted: July 20, 2026

Record last verified: 2026-06

Locations

US (1)